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1 Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
Influenza vaccine production capacity in the South-East Asia Region(SEAR)
Dr. Pushpa Ranjan Wijesinghe Medical Officer ( Emerging VPD Surveilance )
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2 Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
Global Action Plan (GAP) for influenza vaccines
A comprehensive strategy to reduce the present global shortage of seasonal and pandemic Influenza vaccines
Development of GAP 1 in 2006 in a wide consultation
Transition from GAP 1 to GAP 2
based on lessons from H1N1pdm 2009 and H5N1 epidemic
to ensure access, affordability and effective deployment
Three major objectives
Increase in seasonal vaccine use
Increase in vaccine production capacity
Research and development
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3 Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
Objective 1 : Increase in seasonal vaccine use
A win-win relationship for public-private partnership
Demand generation for investment by manufacturers
Trigger for industry to develop a greater capacity for influenza vaccines production
Opportunity to express social responsibility for greater well being of the global community
Helps
Project the demand to meet with the adequate future supply of seasonal influenza vaccines
Determine the potential demand of pandemic influenza vaccines
Prepare countries to effectively respond to an eventual pandemic
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4 Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
Regional update on seasonal influenza vaccine use -SEARO
Identified as a “priority” new and underutilized vaccine for the SEAR region
Recommendations of the South East Asia Regional vaccine priority workshop – 11-13 May , 2009
Feasibility assessment of introducing for high risk groups in SEAR recommended
SEAR Immunization Technical Advisory Group (2012)
Systematic vaccination of high risk groups only in Thailand
Haj and Umra pilgrims targeted in Maldives , (Indonesia )
Potential benefits are not delivered to public in other member states
3
Year Thailand
(Doses in millions)
Maldives
(Doses in Millions)
2008 0.52 0.001
2009 2.2 0.003
2010 2.4 0.0032
2011 2.8 0.0035
2012 2.9 0.0037
Is the seasonal influenza vaccine use in SEARO adequate to sustain a reasonable regional influenza vaccine production?
Source : WHO/UNICEF Joint Reporting Form (JRF)
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6 Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
Objective 2 : Increase in vaccine production capacity
Increase vaccine production capacity through
New production facilities
Higher yielding technologies (Live Attenuated Influenza Vaccines (LAIV),adjuvants)
Sustaining it in the inter-pandemic period
Short term goal (2015) : Produce enough pandemic vaccine to immunize two billion people 6 months after transfer of the vaccine prototype strain to vaccine manufacturers
Increase seasonal flu vaccine capacity by 280 million doses in 2016 (1700 m) relative to 2011 capacity ( 1420 m)
Long term goal : Produce enough vaccine to immunize the world's population in 6 months after transfer of the vaccine prototype strain to vaccine manufacturers (6.7 billion doses)
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7
7 Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
Influenza vaccine production capacity since 2006
8
8 Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
Monovalent pandemic – base case ( 3 X) = 5.1 b doses / annum Monovalent Pandemic – best case (11X )-18.6 b doses / annum
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9 Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
Vaccine production targets (GAP) by 2015
Target 1 (Herd immunity target) – 70% of SEAR population with 2 doses within 6 months of availability of pandemic strain= 2.7 billion doses (global target -10 billion doses/6 months )
Seasonal influenza vaccine production capacity per 6 months
– Base (3X)=900 million doses ,
– Best case (11X)= 245 million doses
Target 2 ( equity target ) - 100% of SEAR population with 2 doses within 6 months of availability of pandemic strain = 3.8 billion doses (global target 14 billon doses/6 months)
Seasonal influenza vaccine production capacity per 6 months
– Base (3X)= 1.3 billion doses ,
– Best case (11X)= 345 million doses
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10 Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
Influenza vaccine production capacity in SEARO
company Product Current annual
capacity
Technique Availability of a
licensed product
Bharat biotech HNVAC R pandemic (H1N1)vaccine
Pandemic-5 million ( Target 10-12 million)
Cell derived inactivated using Madin Darby Canine Kidney (MDCK)
Licensed
Panacea biotec PandyFLU R pandemic H1N1 vaccine
Pandemic-11.5 million (target - 45 million)
Egg based (Inactivated Split Virion)
Licensed
Serum Institute
Seasonal -10 million Egg Based (Live attenuated influenza vaccine)
License under process
Nasovac R pandemic (H1N1) nasal vaccine
Pandemic- Plan A -30 million Plan B – 50 million
Egg Based (Live attenuated influenza vaccine)
Licensed/ WHO pre qualified
PT Biofarma , Indonesia
FluBiO* Target : pandemic -20 million doses
Egg based NADFC market authorization
GPO Thailand Target : seasonal -10 million doses , PIIV-30 , PLAIV 300-500 m
Egg based ( Live attenuated influenza vaccine)
Licensed with Thai FDA
1st license product of the WHO technology transfer initiative
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11
11 Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
12
12 Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
Role of SEARO manufacturers in meeting projected scale-up from 2011- 2016
Difference between seasonal flu vaccine production capacity between 2011 and 2016
106M-Asia-
pacific-
25M China
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13 Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
New patents in the globe
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14 Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
Achievements in SEAR
Recognizing self-reliance of domestic vaccine production as a means of ensuring health security and economic stability
Government contributions for industrial scale influenza vaccine manufacturing facilities
Being grantees of the WHO initiative supporting pandemic influenza vaccines
Establishment and expansion of vaccine production capacity
Building staff capacity in
management, production and quality control
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15 Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
Achievements in SEAR
Technology transfer via
(a) “technology transfer hub” (b) bi-lateral agreements
Acquiring egg based and cell based technology
Shifting to higher yielding technologies
to enable surge capacity in a pandemic
Bio Farma -the first beneficiary of the initiative “Vaccine Formulation Laboratory”
transferred the generic oil in water adjuvant technology
Initial investments to secure sufficient quantities of quality eggs
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16 Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
Achievements in SEAR
Industrial scale capacity development for trivalent seasonal influenza vaccines (IIV,LAIV)
to ensure immediate surge capacity for pandemic vaccines (PLAIV,PIV)
3 countries manufacturing vaccines having a licensed vaccine in the market
Ability to contribute to meeting regional and global pandemic influenza needs
Development of H5N1 vaccines based on the experience acquired from H1N1 vaccine production
Relative strengthening of the National Regulatory Authorities
9
17
17 Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
Achievements in SEAR
18
18 Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
Regional challenges
Securing and sustaining policy support and government commitment
Preventing the reduction of the number of manufacturers due to low return in investment
drop from 7 to 5 in SEAR
Ensuring sufficient domestic market by increased use of seasonal influenza vaccines in the region
Further expanding and sustain superior yield technology to increase production capacity in a pandemic
Optimization and scaling up of the quality control methods
10
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19 Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
Regional challenges
Establishing an effective and sustainable supply of pre-master seeds with other necessary reagents for LAIV
Optimizing processes to obtain high virus yields and volumes of harvested allantoic fluids by providing quality eggs
Inculcating better management capacity with new high yielding technology based production
Enhancing the capacity of NRAs in relation to approving LAIV
Ensuring the public confidence in quality and efficacy of vaccine produced in the region by new manufacturers
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20 Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
Way forward
Maintaining industrial scale production through regular use of seasonal influenza vaccines to serve as a reserve for pandemic response
Mobilizing additional financial support for industrial-scale production
Developing extensive domestic, regional and international networking
Improving capacity through comprehensive collaborative programmes with partners including WHO and its TAG
Establishing effective research and production management capacity through in-house and external training
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21 Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
Way forward
Investments on clean egg supply, negotiations with local producers and international suppliers of embryonated eggs
While pursuing the egg based technology, capitalizing on cell based technology ( R&D)
Strengthening regulatory capacity for timely processing production, GMP approval, product registration and market authorization
Institutional structures and coordination mechanisms
Applying for WHO prequalification as a means of ensuring public and media confidence on the safety and efficacy
22
22 Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
Summary
Recognizing investment in domestic production capacity as a health security and economic stability measure by member states with vaccine production potential
Competitive private sector business model and public sector national security model
Significant expansion of the regional capacity since 2006 following the GAP
Need for sustaining the production capacity through regular use of seasonal influenza vaccination as a reserve for pandemic response
Insufficient use of seasonal influenza vaccines – an impediment for this strategy
12
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23 Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
Thailand – A role model for the SEAR
“Investing in domestic seasonal influenza vaccine production with a readiness to convert to pandemic vaccines is like investment in fighter air-crafts, missiles tanks and submarines “
Public investment for national security
Strategic sustenance of the local capacity
Evidence based demand generation
Capacity for the local and regional support
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24 Seventh meeting of the NICs and Influenza surveillance in the Western
Pacific and South-East Asia region ,
Beijing, China 12-15 November 2013
Acknowledgement
Some global slides - courtesy presentations of Marie-Paule Kieny of WHO
Some information – courtesy presentations of
Dr. Suwit Wibulpolpresert – MOPH Thailand
GPO Thailand
Dr.Opart Kankawinpong –MOPH Thailand
Mr.Stephan Guichard – RA , Vaccine Safety and Quality for his inputs
Coordinator and other colleagues of the IVD for their guidance and comments